D-0698-2018 Class III Terminated
FDA drug recall D-0698-2018 was initiated by InvaGen Pharmaceuticals, Inc. on March 5, 2018 and is designated Class III. Reason for recall: Failed impurities/degradation specifications: Failure to water content and impurity The recall status is terminated (terminated January 20, 2021). Affected quantity: 3222 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 18, 2018
- Initiation Date
- March 5, 2018
- Termination Date
- January 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3222 vials
Product Description
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Reason for Recall
Failed impurities/degradation specifications: Failure to water content and impurity
Distribution Pattern
U.S.A. nationwide
Code Information
Lot #: GE70493, GE70502, GE70512, Exp 8/2019